FDA.reportPublic FDA data

Application 203030

Type
ANDA
Sponsor
UNICHEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOSARTAN POTASSIUMLOSARTAN POTASSIUMTABLET;ORAL25MGNoNo
002LOSARTAN POTASSIUMLOSARTAN POTASSIUMTABLET;ORAL50MGNoNo
003LOSARTAN POTASSIUMLOSARTAN POTASSIUMTABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
29300-144Losartan PotassiumLosartan PotassiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-144Losartan PotassiumLosartan PotassiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-144Losartan PotassiumLosartan PotassiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-144Losartan PotassiumLosartan PotassiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-144Losartan PotassiumLosartan PotassiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-145Losartan PotassiumLosartan PotassiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-145Losartan PotassiumLosartan PotassiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-145Losartan PotassiumLosartan PotassiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-145Losartan PotassiumLosartan PotassiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-145Losartan PotassiumLosartan PotassiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-146Losartan PotassiumLosartan PotassiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-146Losartan PotassiumLosartan PotassiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-146Losartan PotassiumLosartan PotassiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-146Losartan PotassiumLosartan PotassiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-146Losartan PotassiumLosartan PotassiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32348ORIG2015-10-21